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Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Primary Purpose

Cataract, Lens Opacity

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Implantation of IOL: PhysIOL POD F GF
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, trifocal, cataract, PhysIOL

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cataracteous eyes with no comorbidity
  • Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Exclusion Criteria:

  • Unrealistic expectation
  • Irregular astigmatism
  • Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
  • Difficulty for cooperation (distance from their home, general health condition)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
  • Any ocular comorbidity
  • History of ocular trauma or prior ocular surgery including refractive procedures
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
  • Complicated surgery

Sites / Locations

  • Vision Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IOL Implantation

Arm Description

Implantation of IOL: PhysIOL POD F GF

Outcomes

Primary Outcome Measures

binocular Distance Corrected Near Visual Acuity (DCNVA)
measured in logMAR

Secondary Outcome Measures

monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
measured in logMAR
monocular and binocular Corrected Distance Visual Acuity (CDVA)
measured in logMAR
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
measured in logMAR
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
measured in logMAR
monocular and binocular Uncorrected Near Visual Acuity (UNVA)
measured in logMAR
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
measured in logMAR
Contrast Sensitivity (mesopic and photopic)
measured in logCS

Full Information

First Posted
January 16, 2017
Last Updated
May 5, 2021
Sponsor
Beaver-Visitec International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03027024
Brief Title
Clinical Study to Investigate Visual Performance of IOL: FineVision HP
Official Title
Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
October 22, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.
Detailed Description
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacity
Keywords
Intraocular Lens, trifocal, cataract, PhysIOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOL Implantation
Arm Type
Experimental
Arm Description
Implantation of IOL: PhysIOL POD F GF
Intervention Type
Device
Intervention Name(s)
Implantation of IOL: PhysIOL POD F GF
Other Intervention Name(s)
PhysIOL HP
Intervention Description
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Primary Outcome Measure Information:
Title
binocular Distance Corrected Near Visual Acuity (DCNVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Secondary Outcome Measure Information:
Title
monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Title
monocular and binocular Corrected Distance Visual Acuity (CDVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Title
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Title
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Title
monocular and binocular Uncorrected Near Visual Acuity (UNVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Title
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
Description
measured in logMAR
Time Frame
3 months postoperative
Title
Contrast Sensitivity (mesopic and photopic)
Description
measured in logCS
Time Frame
3 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cataracteous eyes with no comorbidity Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent Exclusion Criteria: Unrealistic expectation Irregular astigmatism Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry) Difficulty for cooperation (distance from their home, general health condition) Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…) Any ocular comorbidity History of ocular trauma or prior ocular surgery including refractive procedures Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome) Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) Complicated surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uday Bhatt, MD
Organizational Affiliation
Vision Eye Institute - Footscray
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision Eye Institute
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Study to Investigate Visual Performance of IOL: FineVision HP

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